Tavapadon for Parkinson's Disease

(TEMPO-2 Trial)

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Cerevel Therapeutics, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called tavapadon to see if it can help people with Parkinson's Disease. The study will check how well the medication works, how safe it is, and how the body processes it. Tavapadon aims to balance brain chemicals that control movement, potentially reducing Parkinson's symptoms.

Research Team

ABBVIE Inc.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for men and women aged 40-80 with early Parkinson's Disease (PD) who need medication to manage their condition. They must not have used PD medications recently, agree to birth control if applicable, and be able to follow the study rules. People with dementia, significant heart issues, drug abuse history, or certain other health problems can't join.

Inclusion Criteria

I agree to use effective birth control or remain abstinent during and 4 weeks after the trial.

My condition has worsened in the last 3 years and it started less than 3 years ago.

I can sign the consent form and follow the study's requirements.

Exclusion Criteria

I have a condition that might affect how my body absorbs medication.

I have moderate to severe kidney problems.

You are at risk of hurting yourself.

Treatment Details

Interventions

• Placebo (Drug)
• Tavapadon (Dopamine Agonist)

Trial Overview The trial is testing tavapadon against a placebo in people with early PD. It aims to see how well tavapadon works and its effects on the body when doses are adjusted based on patients' needs compared to no active treatment.

Participant Groups

Group I: Tavapadon Experimental Treatment 1 Intervention

Participants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (QD) orally for 27 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

Who Is Running the Clinical Trial?

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+